Monthly Archives: July 2018

Janssen Pharmaceuticals, part of Johnson & Johnson, has stopped production of (brand-name) Levaquin, according to the article, “Drug maker stopped making popular antibiotic Levaquin amid concerns about mental health side effects” published on the Indianapolis ABC affiliate RTV6 The Indy Channel. Janssen/J&J stopped producing both oral and IV Levaquin in December, 2017. The discontinuation of Levaquin production was confirmed by a Janssen/J&J spokesperson who stated, “The decision to discontinue LEVAQUIN was made due to the wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs.” Though that statement is BS propaganda, it is a direct confirmation from a Janssen Pharmaceuticals spokesperson that JANSSEN/JOHNSON & JOHNSON HAS DISCONTINUED PRODUCTION OF LEVAQUIN.

THIS IS REALLY BIG NEWS! IT’S HUGE! WHOA!

LEVAQUIN HAS BEEN REMOVED FROM THE MARKET!

Unfortunately, there is still plenty of levofloxacin (generic Levaquin, made by hundreds or thousands of generic pharmaceutical producers) on the market, and it is maiming (and killing) thousands of people each year. The fight against these drugs is far from over.

Still, the removal of brand-name LEVAQUIN from the market is a really big deal, and it’s something that we, as a community, should celebrate.

“Never doubt that a small group of committed people can change the world. Indeed it is the only thing that ever has.”—Margaret Mead

I never thought that one of the pharmaceutical giants that has made billions from fluroquinolones would stop making them. Janssen Pharmaceuticals and J&J are huge–they are behemoths–and I never thought that we could move or effect them. But we did.

The efforts of everyone in the “floxie” community contributed to this outcome. We–you–should be proud.

That is my optimistic take on things. We all have an optimistic side. We all have a pessimistic side too, and here’s the bad news.

Victims of pharmaceuticals can’t sue drug-makers for harming them, they can only sue for “failure to warn” of the dangers of the drugs. This is ridiculous – I can sue you for hitting me in the face with a sledgehammer even if you warn me that you’re going to do it and that it’s going to hurt – but pharmaceutical companies aren’t held to the same standards as you or me. It’s assumed that their deadly products are mainly good and that warning of the potential for bad effects is sufficient to wash their hands of liability and responsibility. On top of that, they don’t even have to directly warn YOU, they only have to say that they warned your doctor, the “learned intermediary” of the dangers of the drugs (or, at least they have to in theory – it’s assumed that doctors actually know what’s on the warning labels for pharmaceuticals… but most don’t). Both the “failure to warn” notion and the “learned intermediary” notions are crap, and I hate them, but they’re how the system is set up.

In July, 2008, fluoroquinolone warning labels were changed to note that, “FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients.” – Drug Safety Communication

With each of these warning label changes, the door opened for people to sue Janssen and Johnson & Johnson for the harm that Levaquin did to them. (It should be noted that each of these warning labels changed because of advocacy done by the “floxie” community. We screamed, and, slowly, the FDA listened.) Some people did successfully sue the drug companies that hurt them–they gained some compensation and justice.

Perhaps it’s cynical, but it certainly seems more logical than the BS explanation the Janssen spokesperson gave (noted above) that the reason that Janssen Pharmaceuticals took Levaquin off the market was because they didn’t want to be held liable for the blood sugar level changes and the mental health side-effects of Levaquin. They weren’t making much money off it anyhow (because of generics taking the bulk of the market share), this warning label update opened up a new load of liability, and they did a cost-benefit analysis that led them to take it off the market.

All’s well that ends well, and they took Levaquin off the market, and that’s a good thing, right? Well, it’s more complicated than that.

Because of a stupid and asinine rule put in place by the FDA and a lousy decision of the Supreme Court, victims of generic pharmaceuticals cannot sue generic pharmaceutical manufacturers. It all goes back to the “failure to warn” rules noted above. The FDA says that only brand-name drug manufacturers can change drug warning labels, and since generic drug manufacturers can’t change the warning labels, they cannot be held responsible for what’s on the warning labels. This results in victims of generic drugs being unable to hold anyone responsible for the harm done to them by the drugs. There have been a couple cases where brand-name drug companies were held responsible for the harm done by generic drugs, but the precedent wasn’t set very solidly, and most attorneys in most states still aren’t taking cases of people who have been hurt by generic pharmaceuticals. Still, I think that Janssen and J&J saw the writing on the wall–that they could potentially be held responsible for all the Levaquin and levofloxacin-induced mental health side effects, permanently disabling side effects, permanent peripheral neuropathy, tendon tears, and more. So, they hedged their bets. Their legal team, I’m betting, will now argue that they can’t be held responsible for the harm done by levofloxacin because they don’t even make Levaquin any more, and how can they be held responsible for a product that they don’t even produce? My reply is that they can, and should, be held responsible for the drug that THEY CREATED. Johnson & Johnson created and held the patent on Levaquin for a long time. They made billions of dollars off of it. They can, and should, be held responsible for the effects of their creation. The generic drug companies should also be held responsible for the harm that their drugs do, and the FDA should be held responsible for their warning labels (and failure to warn the public about these incredibly dangerous drugs).

We should also be diligent about the consequences of the removal of Levaquin from the market, and we should continue to work for change in the legal/justice system so that it leans more toward justice for victims, and less toward corporate protection. It is horridly difficult for victims of pharmaceuticals to gain justice or compensation through the legal system as it is currently set up. Janssen pharmaceuticals just made a move to make it even more difficult for victims of Levaquin and levofloxacin to gain justice.

Know what they’re doing. Stay on top of them. Celebrate our victories, then come back to the battlefield fighting. As long as millions of prescriptions of levofloxacin are distributed each year, and thousands of people are maimed by the drugs, our fight isn’t over.

Ruth wrote this as an update/guest post. You can read Ruth’s story of fluoroquinolone toxicity in “Ruth’s Story – Cipro Toxicity.” You can also listen to Ruth’s story through her episode of The Floxie Hope Podcast. Ruth has offered her insight and wisdom to thousands of “floxies” over the years. As of the publishing of this post, her story has almost 1,600 comments. If you read through them, you will see how Ruth has generously given her time, insight, wisdom, and advice to those who are struggling. The comments are just a small sampling of what she has given to the fluoroquinolone toxicity community. Ruth has given so much to others while going through the ups and downs of fluoroquinolone toxicity herself. She is a kind, thoughtful, generous, person, and I am honored to call her a friend. As you will see from the post below, she can use a bit of encouragement and appreciation, so I’ll take the time to say thank you to her. THANK YOU, RUTH!

Floxiehope update 7/19/18

I’m not 100% healed yet. I had another relapse lasting a few months during the second half of this school year. My blood pressure kept going up in response to doing just about anything. I felt overwhelmed just about all the time. Earlier in the school year I would go work out after school and feel marvelous afterward. When the relapse started by the time my teaching day ended my blood pressure would be up way too high for me to exercise. This caused my base line blood pressure to hover around 140/90, which is what happens when I don’t do any cardio. But by the end of a day it would be 170/110 or higher.

Friends kept telling me to go on medication for high blood pressure but I just didn’t feel like my problem was with the cardiovascular system. It seemed like my autonomic nervous system was sending the wrong message and that was what was ramping up my blood pressure and heart rate. If I was about to be eaten by a bear, this would have been an appropriate response. My body was responding to the stimulation of a normal teaching day as if I was in mortal danger. But like most flox symptoms, I knew this could stop happening at any moment, and I really did not want to be on strong antihypertensives when that happened.

Since the school year ended I have been feeling better. Still mildly hypertensive, but better. I need to clean up my diet and exercise more. I’m working on that but I have not been checking my BP right now as if it is a little high that upsets me, which is counterproductive at this point. I don’t get that feeling of increasing anxiety, of things being overwhelming or of my blood pressure sky rocketing. If anything I feel a lot more normal than I have for years.

Not being able to work out definitely hurt me when fireworks season started, so I got really sore. At first my back hurt, then my core and abs hurt and then nothing hurt and I could lift whatever I needed to. It was amazing how fast my body recovered and gained strength. I’ve been more motivated to work out and especially to strengthen my core.

I would say the most troubling aspect of my post flox life right now is new floxies who ask me for advice and then get completely freaked out that I still have relapses and am not symptom free. They accuse me of lying to them. They block me on Facebook. They tell me I have not really healed very much and they need to find someone to talk to who has healed. Once again, I felt the temptation to turn my back on the flox community forever. It seems that since I didn’t heal 100% some floxies feel I have nothing to say. I almost believed them.

But my story is my story. My healing journey is my own and no one else’s. It is my belief that I will see 100% healing but I think it will take between six to seven years total. I think the very stressful job I had prior to this year pushed my nervous system to make more repairs and when it did that I felt it. I think this year I pushed myself way too hard doing administrative tasks for teaching with a nervous system that still does not like too much of that kind of thing. I love my new school and Wisconsin has merit based pay for teachers. I put in a lot of time on grades and lesson plans so that at the end of the year I had the documentation I needed to show I did my job. It pushed my nervous system when I was spending ten hours on my day off doing stuff for school. That’s a long time to sit and enter data into a computer. For anybody.

I think also there is an emotional aspect to dealing with getting floxed and I couldn’t do it right away. I couldn’t even cry without it feeling like someone was squeezing my brain. I didn’t have normal emotions for years. Aspects of my personality were missing that didn’t come back until year three. Suddenly, this school year, I had the emotional capacity to ask, “What just happened to me? How do I feel about this? Am I coping all right with this?”

I was so busy though, working so hard at my teaching job and I did a lot of arranging music for my choir this year also. They do better with three part music than four part, so I arranged public domain hymns into three part choir anthems. Between the two jobs every spare minute was spent concentrating, bent over a computer screen. But my brain didn’t want to concentrate on all that stuff or on teaching my classes, it wanted to process what had happened to me when the flox bomb went off in my body and brain four years ago. Some of what I was experiencing toward the end of this school year may actually have been PTSD.

So as fireworks season winds down and I have more time I am working at healing not just my nervous system but my spirit. I’m giving my brain time to just do nothing, think of nothing. I’m giving my body time in nature to just experience things like swimming and hiking. I have had to let go of the dream of a perfectly clean house before school starts. I have had to allow myself time to heal. Not physically. I am pretty much physically healed. Time to heal mentally, emotionally and spiritually.

I probably am still lacking a few receptors for gamma amino butryic acid compared to if I had not been floxed. I do believe that those will be replaced eventually because I believe in neural plasticity.

I am still a bit low on magnesium, but now it takes working hours in 95 degree heat and humidity for me to notice it. My teeth started to feel loose while I was drenched in sweat working to set up fireworks shows, but as soon as I took some magnesium they tightened up and the anxiety I had felt building went away. I used to notice symptoms of magnesium deficiency like that if I didn’t take some every two hours just sitting around indoors.

I used to have to eat breakfast and take a magnesium pill the moment I woke up. Now I walk two miles or more before breakfast and I don’t always remember to take magnesium before I do it. I have noticed that my legs don’t hurt no matter how much I walk or stand. It takes a lot for me to get physically tired. So I am making progress, and I definitely think my cells will once again be healthy and filled with magnesium and I won’t have to take as much as many magnesium pills as I do now to keep them that way.

I think what really remains for me to reach 100% healing is for me to completely come to terms with what happened to me, to recover from the PTSD the experience seems to have caused. I was in a situation in which my body was failing me, I didn’t know how bad it was going to get or even if I would die. The flox bomb going off can cause some shell shock. Only if you have experienced it can you understand that, and realize I am not meaning to diminish the PTSD experienced by our soldiers. But like them, keeping busy can only delay the PTSD symptoms. Eventually, our mind says, “Hey, this thing happened, and it was really bad, and I really need some help to cope with it, because I really couldn’t cope at the time and I’m not sure I can now.” We can get physical symptoms that are a manifestation of our inability to cope– like my blood pressure and heart rate constantly becoming elevated. I wasn’t overwhelmed with my teaching duties, per se, although I may have pushed a little nervous system healing by doing so much computer work. What really caused my last relapse was my absolute need to stop, to pause, to reflect, to heal from that flox bomb. Not physically. That part of my healing is very nearly complete. I need to heal mentally.

I need to stop and rest so that my mind can process what happened and be ok with it and pause and see that I really am ok now.

I think what I have to say has value even though I am not 100% recovered yet. It would be nice if there were some magic pill, a miracle cure that could make flox damage go away instantly. There’s not. And even after the physical damage heals, there is the emotional aftermath. Personally, I think someone who has coped with the flox bomb for four and half years may just be able to give better advice about coping with getting floxed than the person who managed to heal in a few weeks. Even if a floxie does everything the quick healer did it does mean he or she will heal as quickly. We are all different. There are no guarantees. There is no protocol for treating FQAD. It’s great when someone can share a supplement they took and someone else feels a bit better from it, but none of us are sharing overnight cures, because there are none.

Getting floxed does a tremendous amount of damage to the human body. That the body can heal it is amazing. That it can take a significant amount of time to do so is frustrating. That it sometimes cannot heal all the damage is a real possibility. Talking to people who healed slowly, who faced the fact that they were damaged badly enough that they may not heal all the way, is going to provide wisdom that is way more important than what supplement or treatment you could try.

I have always believed that improving parasympathetic nervous system function was at the core of healing floxies. Learning coping skills is all about choosing “rest and digest” over “fight or flight” no matter what is happening to you. Not saying it’s easy. But it’s a choice of learning to live life despite your circumstances, or deciding your life is over because your circumstances aren’t good. I have learned to make a great life for myself even when my circumstances were pretty crummy.

When I look back over the past four and half years, most of my memories are good. There are some pretty horrible ones in there too, but once I got past about month four or five, I could live even with the symptoms I had. When I look back on those times I remember the things I did, my accomplishments, and the people I spent time with. I really don’t remember the symptoms I was having, or if I do it is in passing and they certainly don’t dominate my memories.

Here’s something else to consider. How many people do you know with perfect health? Everybody has some issue(s) they are dealing with. Some of the middle aged women who work at my school have told me of their struggles with menopause and I have to say, other than that rough stretch toward the end of the school year, I generally feel a lot better than they do. I’m floxed, yes, but I can think of a lot of people who aren’t floxies who aren’t as healthy or as active as I am.

I’m four and a half years out and I still have some healing to do. But when I look at where I started compared to how I feel today, I know I am blessed. I’m incredibly saddened when floxies decide I have nothing to say to them because I didn’t heal 100% yet.

I think we need to treat one another better in the flox community. I actually know of some people who healed 100% who no longer are willing to support other floxies. Perhaps the behavior of floxies seeking help actually drove them away from the flox community. When seeking out advice of another floxed person, it is important not to forget that this person probably went through hell and may still be struggling with issues, struggling to cope with what happened to them, just as you are. Most are happy to share advice and emotional support, but few of us are medical professionals and we aren’t getting paid to help other floxies. We do that out of the goodness of our hearts. If advice we give isn’t helpful, then say thank you and move on. But don’t expect any floxie to have the magic bullet. There isn’t one. It is going to take time for you to heal.

Our society does not like to admit that some things that are painful are going to be that way for awhile. When I was widowed back in 1993 I had friends tell me that if I was still feeling sad in a month or two there is probably something wrong and I would need to get some professional help. I know a floxie who was prescribed Benzodiazepines because she lost a loved one. When she took Cipro it threw her into Benzo withdrawal, but she would never have been in that situation but for this idea that any suffering is intolerable and must be medicated away. This may be why our medical system does such a terrible job of treating chronic illness. It is quicker to prescribe a pain pill to get rid of the symptoms than to really dig into the cause of the illness.

Anyone who has dealt with grief knows the time line my friends suggested when my husband died was way out of whack. The floxie time line is more similar to the grief time line than anything else I can think of. And like grief, it may never totally go away. It will never be as if you had not loved and lost. You are forever changed. It will never be as if you were never floxed. I am forever changed because I got floxed even if I have more healthy mitochondria then when I started, if every cell of my body is brimming with magnesium and all my antioxidants are functioning beautifully and if I have more GABA receptors than I started with, I still experienced the flox bomb go off in my body and it was beyond horrible. That experience will always be with me as much as the moment I heard that my husband had been killed.

A few Sundays ago I played a hymn in church that had comforted me after Danny died, and suddenly I was crying so hard that I couldn’t sing and it was like I was 25 years old again and going through all that grief the first time. Some wounds don’t ever really go away, but you can live with them. You can survive and thrive and sometimes, even grief feels good. I can cry again without it feeling like someone is squeezing my brain. How I cherish that blessed release tears can bring!Now I can cry about the flox bomb too, and probably, if I live to be 80, there will be a day that a certain memory hits me and I cry about getting floxed all over again.

I am just asking floxies who seek advice from other floxies to keep in mind that what we are all dealing with is a chronic illness. It lasts a long time for just about everyone. Some people are able to heal from it, which is amazing and wonderful. But even those who don’t heal, but learn to cope, have done a tremendous thing and overcome a lot. They should be celebrated and listened to, because learning to cope is over half the battle, and some scars are simply going to be there forever. It is way past time for the medical community to stop doing this to people. But at least we can treat each other well.

** The story above is truthful, accurate and told to the best of the ability of the writer. It is not intended as medical advice. No person who submits his or her story, nor the people associated with Floxie Hope, diagnoses or treats any illness. The story above should not be substituted for professionally provided medical advice. Please consult your doctor before trying anything that has been mentioned in this story, or in any other story on this site. Please also note that people have varying responses to the treatments mentioned in each story. What helps one person may not help, and may even hurt, another person. It is important that you understand that supplements, IVs, essential oils, and all other treatments, effect people differently depending on the millions of variables that make each of us unique. Please use appropriate caution and prudence, and get professional medical advice.

On 7/10/18 the FDA announced that fluoroquinolone (Ciprofloxacin, Levofloxacin, Moxifloxacin, Ofloxacin, and a few others) warning labels are to be updated to include adverse effects on blood-sugar levels, as well as serious mental health effects:

WE know about the blood sugar and psychiatric effects of fluoroquinolones. The FDA does too. Now they have acknowledged that they know about these horrible, life-altering, sometimes life-threatening effects of fluoroquinolones.

This acknowledgement from the FDA is a big step in the direction of getting fluoroquinolone toxicity more widely acknowledged. However, whenever there are updates to the warning labels, there are many people who say, “so what? It’s just a warning label that no one pays attention to. When is the FDA going to really DO SOMETHING to fix this problem – like find a cure for fluoroquinolone toxicity and/or remove FQs from the market?” Those people have plenty of good points, and I went into some depth in addressing them in the post, “Change the Warning Labels: Why it Matters.” In that post, I assert that one of the things that changes to warning labels does is open the door for people to sue the drug-makers:

“Warning labels themselves may be useless, but during the time when a warning label has things added to it, they can be a great tool, and a big gun we can use against the pharmaceutical companies. The ONLY times lawyers are willing to take cases to sue the drug companies are when warning labels change. For example, when the fluoroquinolone warning labels were adjusted in August, 2013 to note that permanent peripheral neuropathy is a possible effect of fluoroquinolones, several law firms took cases of those who are suffering from peripheral neuropathy after taking fluoroquinolones. Before the warning label changed, they wouldn’t take the cases, because, appallingly, you can’t sue drug companies for hurting you, you can only sue them for “failure to warn” of the harm they’ll do. It’s a really stupid situation and stupid system. BUT, the time when warning labels change is the brief period of time in which you can sue the drug companies for “failure to warn” and it’s the brief period of time when we have the chance to fight the pharmaceutical companies.”

Everyone who has suffered from hypoglycemia or mental health issues post-fluoroquinolone exposure now has a window open to file a lawsuit against the pharmaceutical companies that made the drugs that hurt them. Here are some law firms that have taken fluoroquinolone-harm cases in the past:

There are others too (feel free to let me know if you know of firms that are taking these cases). I hope that Bayer, Johnson & Johnson/Jansen Pharmaceuticals, and all the generic producers of fluoroquinolones pay for the harm that their products are doing to people, and I encourage all victims to seek justice through the legal system.

I hope that this warning label change will help fluoroquinolone toxicity victims to gain acknowledgement and justice. Everyone who has been hurt by these drugs deserves both.

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Two guidebooks for getting through fluoroquinolone toxicity

The Fluoroquinolone Toxicity Solution + The Floxie Food Guide:

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